Press Release

DIASORIN GROUP REPORTS GROWTH IN REVENUES AND NET PROFIT

IN THE FIRST NINE MONTHS OF 2018

MAIN FIRST 9 MONTHS 2018 RESULTS

REVENUES: € 494.0 million, +5.4% (+9.1% at CER; negative impact of exchange rates on revenues amounting to € 17.5 million). Solid sales performance of CLIA immunodiagnostic tests, net of Vitamin D, and Siemens' ELISA Business. Negative trend in Vitamin D sales, mainly as a result of the performance in the U.S. market; downward trend in ELISA Murex sales (primarily in certain countries served through distributors, in China and in Brazil).

EBITDA: € 187.1 million, +2.7% (+7.5% at CER; negative impact of exchange rates on revenues amounting to € 8.8 million), equal to 37.9% of Group revenues (38.3% at CER).

Profitability at CER in line with the first 9 months of 2017, despite costs incurred for a legal action between DiaSorin and Meridian that successfully ended on October 9, 20181, and costs to divest the Irish manufacturing facility.

NET PROFIT: € 116.8 million, +22.0%, equal to 23.6% of Group revenues and a Group tax rate equal to 22.2% (32.0% in the first 9 months of 2017), following the positive effects arising from Patent Box regime in Italy and Corporate Tax Reform in the U.S.

NET FINANCIAL POSITION: +€ 128.8 million at September 30, 2018 (+€ 149.3 million at December 31, 2017), net of treasury shares' purchase and sale related to Stock Options Plan, amounting to € 65.5 million. The result did not include debts versus shareholders for special dividends for € 98.4 million, as resolved by the Shareholders' Meeting on April 23, 2018.

FREE CASH FLOW: € 100.6 million in the first 9 months of 2018, +3.1% compared to the first 9 months of 2017.

LIAISON/LIAISON XL: net placements of +336 units (+367 LIAISON XL and -31 LIAISON installations) in the first 9 months of 2018, for an overall total of 7,734 units at September 30, 2018, of which 3,885 LIAISON XL (ca. 50% of the total installed base).

1 Press release available in the Investor Relations section atwww.diasorin.com

Saluggia (Italy), November 7, 2018 - The Board of Directors of DiaSorin S.p.A. (FTSE Italia Mid Cap: DIA), a global leader in the production of diagnostic tests, met today in Saluggia under the Chairmanship of Mr. Gustavo Denegri, and examined and approved the consolidated economic and financial results of the first 9 months of 2018.

TABLES OF RESULTS

9M

change

2017

2018

amount

% @ current

% @ CER

Revenues

468.6

494.0

+25.3

+5.4%

+9.1%

CLIA tests ELISA tests Molecular tests

Instruments sales and other revenues

315.9 56.9 40.0 55.9

325.4 70.0 40.6 57.9

+9.6 +13.1 +0.6 +2.0

+3.0% +23.0% +1.6% +3.6%

+6.4% +27.3% +8.5% +6.5%

EBITDA

182.2

187.1

+5.0

+2.7%

+7.5%

EBITDA margin

38.9%

37.9%

-99 bps

EBIT

144.8

149.3

+4.5

+3.1%

EBIT margin

30.9%

30.2%

-67 bps

Net profit

95.7

116.8

+21.1

+22.0%

Q3

change

2017

2018

amount

% @ current

% @ CER

Revenues

149.4

162.8

+13.4

+9.0%

+9.5%

CLIA tests ELISA tests Molecular tests

Instruments sales and other revenues

102.5 19.1 10.7 17.1

108.3 23.8 11.1 19.7

+5.7 +4.7 +0.4 +2.6

+5.6% +24.7% +4.0% +15.0%

+6.3% +25.9% -0.0% +16.5%

EBITDA

56.0

58.9

+3.0

+5.3%

+6.8%

EBITDA margin

37.5%

36.2%

-128 bps

EBIT

43.7

46.3

+2.6

+6.0%

EBIT margin

29.2%

28.4%

-79 bps

Net profit

29.3

35.9

+6.6

+22.7%

SIGNIFICANT EVENTS

IMMUNODIAGNOSTICS

BUSINESS DEVELOPMENT

  • LIAISON QUANTIFERON-TB GOLD PLUS: launched in Europe, in partnership with Qiagen, to detect latent tubercolosis infection (LTBI) on LIAISON analyzers. The new test will help address accelerating conversion of the global LTBI testing market to the modern blood-based QuantiFERON technology.

  • STRATEGIC COLLABORATION WITH MERIDIAN TO SELL HELICOBACTER PYLORI STOOL ANTIGEN TEST IN THE UNITED STATES AND IN THE UNITED KINGDOM: strategic collaboration to sell DiaSorin's Helicobacter pylori stool antigen test for use on its automated LIAISON platforms under the Meridian brand name worlwide. This new collaboration resulted in the termination of all pending legal disputes and will expand the scope of the previous agreement between DiaSorin and Meridian, which provided for the sale by DiaSorin of co-developed products in major countries in continental Europe, to market the LIAISON H. pylori in the U.S. and UK.

PRODUCTS DEVELOPMENT ON LIAISON/LIAISON XL

LIAISON BRAHMS PCT II GEN: clearance to market in the U.S. the assay for Sepsi's diagnosis through the quantitative determination of procalcitonin (PCT).

LIAISON XL MUREX ANTI-HDV: clearance to market in Europe the specialty assay for the diagnosis of Hepatitis D virus

(HDV), completing the CLIA menu for Hepatitis and Retrovirus available on LIAISON instruments. The launch of this specialty test confirms DiaSorin as the Company with the widest CLIA menu in this clinical area.

MOLECULAR DIAGNOSTICS

PRODUCTS DEVELOPMENT (KITS & ASRS - ANALYTE SPECIFIC REAGENTS) ON LIAISON MDX

  • Kit: HSV 1 & 2, certification to extend the analyzable claims in the U.S. with Simplexa HSV 1 & 2 molecular kit on the "Direct Amplification Disc".

  • Kit: VZV Direct, CE marking for Simplexa VZV Direct test.

  • Kit: Group B Streptococcus, CE marking for Simplexa Group B Strep Direct assay and submission to the FDA, under their Premarket Notification process, to obtain 510(k) Clearance for the U.S. market.

  • ASR: Anaplasma phagocytophilum, Ehrlichia and Babesia for the identification of infections caused by these pathogens, commonly carried by ticks.

COMMENT ON RESULTS

The foreign exchange market in the first 9 months of 2018 highlighted an appreciation of the Euro against the main currencies in which the Group operates vs. the first nine months of 2017.

U.S. Dollar

Brazilian

Real

Chinese Yuan

Australian

Dollar

Mexican

Peso

British Pound

Euro

+7.2%

+21.5%

+2.7%

+8.4%

+8.2%

+1.2%

Source: Banca d'Italia

CONSOLIDATED REVENUES

Revenues: € 494.0 million in the first 9 months of 2018, +5.4% (+9.1% at CER) compared to the first 9 months of 2017, on the back of Siemens' ELISA Business solid performance (acquired in September 2017), CLIA sales, net of Vitamin D, and molecular diagnostic kits sales. The unfavorable impact of foreign exchange rates on the first 9 months of 2018 was € 17.5 million.

  • CLIA, net of Vitamin D: +7.5% (+10.3% at CER)

  • Vitamin D (CLIA): -8.1% (-3.3% at CER)

  • ELISA tests: +23.0% (+27.3% at CER)

  • Molecular tests: +1.6% (+8.5% at CER)

  • Instruments sales and other revenues: +3.6% (+6.5% at CER)

In the first 9 months of 2018, the net balance of units installed amounted to +336, increasing the total number of installed instruments to 7,734 units. LIAISON XL confirmed its success with +367 instruments installed for an overall total of 3,885 units, equal to ca. 50% of the total installed base.

In Q3'18, revenues increased to € 162.8 million, +9.0% (+9.5% at CER) compared to Q3'17.

Steady growth of CLIA sales, net of Vitamin D, as already recorded in first two quarters of 2018, along with an upward trend in Siemens' Elisa Business and instruments sales. Negative trend in Vitamin D sales, mainly as a result of the performance in the U.S. market. The unfavorable impact of foreign exchange rates on Q3'18 sales was € 0.8 million.

  • CLIA, net of Vitamin D: +8.7% (+9.8% at CER)

  • Vitamin D (CLIA): -3.0% (-3.4% at CER)

  • ELISA tests: +24.7% (+25.9% at CER)

  • Molecular tests: +4.0% (-0.0% at CER)

  • Instruments sales and other revenues: +15.0% (+16.5% at CER)

Revenues by geography

The following tables show the breakdown of the consolidated turnover of the Group by geographic area. Data include sales from Siemens' ELISA Business, acquired in September 2017.

9M

Change

Amounts in millions of euros

2017

2018

amount

%

@ current

@ CER

Europe and Africa

200.0

227.6

+27.6

+13.8%

+14.3%

%on totalrevenues

42.7%

46.1%

North America

149.2

139.3

-10.0

-6.7%

+0.0%

%on totalrevenues

31.8%

28.2%

Asia Pacific

84.9

95.5

+10.6

+12.5%

+16.0%

%on totalrevenues

18.1%

19.3%

Central and South America

34.5

31.5

-2.9

-8.5%

+1.6%

%on totalrevenues

7.4%

6.4%

Total

468.6

494.0

+25.3

+5.4%

+9.1%

Q3

Change

Amounts in millions of euros

2017

2018

amount

%

@ current

@ CER

Europe and Africa

63.6

71.5

+7.9

+12.4%

+12.5%

%on totalrevenues

42.6%

43.9%

North America

45.7

46.1

+0.4

+0.9%

-1.0%

%on totalrevenues

30.6%

28.3%

Asia Pacific

28.8

34.9

+6.1

+21.1%

+23.1%

%on totalrevenues

19.3%

21.4%

Central and South America

11.3

10.4

-0.9

-8.2%

+1.3%

%on totalrevenues

7.6%

6.4%

Total

149.4

162.8

+13.4

+9.0%

+9.5%

Europe and Africa

Revenues in the first 9 months of 2018 were € 227.6 million, +13.8% (+14.3% at CER) compared to the first 9 months of 2017, on the back of Siemens' ELISA Business, CLIA sales, net of Vitamin D, and molecular diagnostic sales.

In Q3'18, revenues were € 71.5 million, +12.4% (+12.5% at CER).

  • Italy:

    9M'18: +9.1% (local market: +4.1%)2; upward trend in Vitamin D and CLIA sales, primarily Gastrointestinal Infections, Vitamin D 1,25, PCT and Hepatitis panels.

    Q3'18: +8.2%.

  • Germany:

    9M'18: +22.7% (local market: +0.4%)2; growth of CLIA sales, net of Vitamin D, primarily Gastrointestinal Infections, Vitamin D 1,25, Infectious Diseases and Fertility panels. Positive contribution from Siemens' Elisa product portfolio; Vitamin D negative performance due to continued price pressure.

    Q3'18: +22.6%; CLIA tests performance slightly increased compared to Q2'18, despite sales were still adversely affected by the distribution network reorganization following the acquisition of Siemens' Elisa Business.

  • France:

    9M'18: +16.3% (local market: +0.9%)2; growth spurred by CLIA sales, net of Vitamin D (+12.6%), specifically Hepatitis, Infectious Diseases and Prenatal Diseases panels. Positive contribution from molecular diagnostic sales.

    Q3'18: +15.9%.

2 Source: latest EDMA data available

North America

Revenues in the first 9 months of 2018 were € 139.3 million, -6.7% (+0.0% at CER) compared to the first 9 months of 2017, due to unfavorable exchange rates. Growth in revenues from CLIA sales, net of Vitamin D, was offset by negative Vitamin D trend.

In Q3'18, revenues were € 46.1 million, +0.9% compared to Q3'17 (-1.0% at CER). Continuing negative performance of Vitamin D sales (-8.4% in the U.S. market) following the implementation of reimbursement policies by a major insurance Group.

Asia Pacific

Revenues in the first 9 months of 2018 were € 95.5 million, +12.5% (+16.0% at CER). Positive sales trend in the Australian market and CLIA revenues continuous growth in China.

In Q3'18, revenues were € 34.9 million, +21.1% (+23.1% at CER).

  • China:

    9M'18: +1.5% in local currency; positive contribution from CLIA sales (+14.0%), primarily Hepatitis, Prenatal Screening, Infectious Diseases, Thyroid and Vitamin D panels, partly offset by the decrease in instruments sales (-15.0%) and ELISA Murex reagents.

    Q3'18: +4.3% in local currency: upward trend buoyed up by good CLIA sales performance (+16.3%), partly offset by a decline in ELISA Murex sales, along with instruments sales, in line with Q3'17.

  • Australia:

    9M'18: +17.1% in local currency; positive CLIA sales trend, particularly Gastrointestinal Infections, Prenatal Screening, Endocrinology and Siemens' ELISA Business.

    Q3'18: +12.4% in local currency.

  • Distributors:

    9M'18: +38.0% (+40.0% at CER) mainly as a result of increased sales of instruments and tests' portfolio acquired from Siemens.

    Q3'18: +64.5% (+64.6% at CER).

Central and South America

Revenues in the first 9 months of 2018 were € 31.5 million, -8.5% (+1.6% at CER), due to adverse exchange rate effect compared to Q2'18.

Revenues in Q3'18 were € 10.4 million, -8.2% (+1.3% at CER) compared to Q3'17.

  • Brazil:

    9M'18: -0.4% in local currency; positive trend in sales of CLIA tests, primarily Vitamin D 1,25 and Hepatitis and Infectious Diseases panels.

    Q3'18: -10.5% in local currency; good CLIA tests' performance offset by the downward trend in sales of Vitamin D, instruments and ELISA Murex panel (as a consequence of payments delays from some public customers).

  • Mexico:

    9M'18: +10.1% in local currency; growth in instruments sales, revenues from Siemens ELISA Business and sales of CLIA tests, particularly Endocrinology, Autoimmunity, Vitamin D 1,25 and Thyroid tests.

    Q3'18: +26.2% in local currency.

  • Distributors:

    9M'18: +0.4% at CER; positive performance of CLIA tests. Q3'18: +6.8% at CER.

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DiaSorin S.p.A. published this content on 07 November 2018 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 07 November 2018 12:22:03 UTC